Reason for Prescribing Rice Infant Formula

Last updated: March 18, 2025
Sponsor: Mead Johnson Nutrition
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Rice infant formula

Clinical Study ID

NCT06318117
3398-1
  • Ages 6-36
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Child aged between 6 and 36 months,

  • Child who has already consumed a RIF for at least one month, or still consuming aRIF, or who will benefit from taking a RIF, according to the pediatrician,

  • Legal representatives (parents/guardians) deemed capable of following therequirements of the protocol and have given their consent orally.

Exclusion

Exclusion Criteria:

  • Child with a clinically relevant and significant abnormality in the medical historyor on physical examination;

  • Child who has been hospitalized in a neonatology unit (due to prematurity,malformation or neonatal pathology), or born with a low birth weight (≤ 2,500 g);

  • For children not diversified at the time of starting RIF: mixed feeding with RIF andbreast milk and/or infant formula based on cow's milk;

  • Child born to minor parent(s);

  • Infant or infant's family unable to comply with study protocol or procedures, in thejudgment of the investigator;

  • Participation in any other clinical trial prior to inclusion;

  • Refusal of the Parents / legal representatives of the child, or who do not masterthe French language well enough to understand the information letter.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Rice infant formula
Phase:
Study Start date:
March 12, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest. Secondary objectives are to describe the modalities of feeding before, during and after consuming the RIF, to describe the growth of children who have consumed a RIF for at least 1 month, on the basis of anthropometric data collected during the first year of life. As a second intention, this study also aims to monitor the evolution of child's digestive and allergic symptoms, if any, and the sociodemographic characteristics of the infant's family.

Connect with a study center

  • Dr Christine REGIMBART - Private Practice

    Bécon-les-Granits, Becon-les-Granits 49026
    France

    Active - Recruiting

  • Scm Les Pediatrices Du Pic St Loup

    St Clement, DE Riviere 34980
    France

    Active - Recruiting

  • Dr Frederic Couttenier Private Practice

    Attiches, 59551
    France

    Active - Recruiting

  • Centre Hospitalier d'Auxerre - Neonatology and pediatric emergency department

    Auxerre, 89011
    France

    Active - Recruiting

  • Elise Foy-Foulkes Private Practice

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

  • Dr. Anne Cheve Private Practice

    Brest, 29200
    France

    Active - Recruiting

  • Dr. Sandra Brancato Private Practice

    Brignon, 30190
    France

    Active - Recruiting

  • Dr. Karim Abada Private Practice

    Foix, 09017
    France

    Active - Recruiting

  • Dr. Nellie Houeto Private Practice

    Hyères, 83400
    France

    Site Not Available

  • Dr. Anne Sengier - Private Practice

    Le Havre, 76600
    France

    Active - Recruiting

  • Dr. Amandine Blasquez Private Practice

    Libourne, 33500
    France

    Active - Recruiting

  • Centre Hospitalier de Montauban - Pediatric Department

    Montauban,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes - Pediatric emergency department

    Nantes, 44093
    France

    Active - Recruiting

  • Dr. Marc Sznajder Private Practice

    Paris, 75011
    France

    Active - Recruiting

  • Hôpital NOVO - Pediatric department

    Pontoise, 95300
    France

    Active - Recruiting

  • Dr Marta Nowak-Mohamed - Private Practice

    Vichy, 03200
    France

    Active - Recruiting

  • Dr. Piotr Gembara Private Practice

    Vichy, 03200
    France

    Active - Recruiting

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